Multicenter Randomized Controlled Clinical Trial to Compare the Safety and Performance of Two Bone Flap Fixation Systems.

BACKGROUND AND

OBJECTIVES

Polymeric clamp-like devices present potential advantages regarding plates and screws to close craniotomies; however, no clinical research has provided enough evidence to compare them. This randomized controlled trial compares the clinical safety and performance of clamp-like devices with the standard of care for craniotomy closure: titanium plates and screws (P&S).

METHODS

A prospective, double-arm, multicenter randomized controlled trial was performed at 3 sites, recruiting 60 patients undergoing neurosurgical interventions requiring craniotomy. Patients were randomly allocated to 2 groups depending on the bone flap fixation system to be used: plates and screws (any brand) and clamp-like devices (Cranial LOOP, NEOS Surgery S.L.). The primary end point of the study (bone flap alignment) was assessed 6 months after surgery through neuroimaging. Secondary end points included adverse events and device deficiency assessment, closure method usability assessed by the surgeon, and patient-reported device-related inconveniences.

RESULTS

It was necessary to use a median of 3 Cranial LOOP and 4 plates and 8 screws to close craniotomies. All patients from both groups had equally good bone flap alignment. Most implantations were reported as easy or very easy for both groups, and surgeons were generally satisfied or very satisfied with both treatments. No related adverse events have been reported for any of the treatment groups. Two patients reported discomfort or protuberances caused by P&S; no inconveniences were reported for Cranial LOOP.

CONCLUSION

Cranial LOOP performance is equal to P&S for fixation of the cranial bone flap. In addition, it presents some advantages, such as the use of a lower number of devices, potentially making this system more affordable, and the lack of discomfort previously linked with the use of P&S.